Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Tacrolimus
Drug ID BADD_D02105
Description Tacrolimus (also FK-506 or Fujimycin) is an immunosuppressive drug whose main use is after organ transplant to reduce the activity of the patient's immune system and so the risk of organ rejection. It is also used in a topical preparation in the treatment of severe atopic dermatitis, severe refractory uveitis after bone marrow transplants, and the skin condition vitiligo. It was discovered in 1984 from the fermentation broth of a Japanese soil sample that contained the bacteria Streptomyces tsukubaensis. Tacrolimus is chemically known as a macrolide. It reduces peptidyl-prolyl isomerase activity by binding to the immunophilin FKBP-12 (FK506 binding protein) creating a new complex. This FKBP12-FK506 complex inhibits calcineurin which inhibits T-lymphocyte signal transduction and IL-2 transcription.
Indications and Usage For use after allogenic organ transplant to reduce the activity of the patient's immune system and so the risk of organ rejection. It was first approved by the FDA in 1994 for use in liver transplantation, this has been extended to include kidney, heart, small bowel, pancreas, lung, trachea, skin, cornea, and limb transplants. It has also been used in a topical preparation in the treatment of severe atopic dermatitis.
Marketing Status Prescription; Discontinued
ATC Code D11AH01; L04AD02
DrugBank ID DB00864
KEGG ID D00107
MeSH ID D016559
PubChem ID 445643
TTD Drug ID D06OMK
NDC Product Code 16729-041; 0781-2104; 70748-219; 52972-0040; 0168-0416; 70748-220; 70377-014; 16729-043; 43353-317; 68254-0002; 49629-022; 0469-1330; 68084-450; 49629-020; 70518-3022; 68462-534; 69452-153; 55111-527; 55111-525; 47848-018; 16714-098; 65897-1010; 38779-2698; 62250-665; 68084-449; 52928-006; 0904-6623; 50222-211; 49629-021; 68992-3075; 45802-700; 43817-423; 63629-8726; 70748-221; 68254-5005; 68462-685; 0781-2103; 69452-154; 50090-2245; 69452-155; 0469-3016; 54288-135; 0904-7097; 0904-6425; 68254-0020; 0378-2047; 73377-010; 60429-378; 50090-5596; 65050-0321; 50222-203; 0781-2102; 16729-042; 68084-451; 0168-0417; 0378-2045; 63629-8725; 0904-6624; 55154-4080; 55486-1576; 45802-390; 51927-0092; 0469-0607; 68308-703; 68254-5004; 60429-377; 68462-686; 64380-721; 0469-0617; 0378-2046; 62991-3072; 67877-278; 43817-421; 64380-720; 51079-028; 64380-722; 70518-3216; 51079-818; 68254-2502; 51187-0006; 55111-526; 70377-015; 70518-2996; 67877-279; 0469-1230; 68254-5006; 65727-009; 0469-0657; 70377-016; 70518-2593; 16729-422; 51079-817; 60429-379; 16729-421; 68992-3040; 16714-100; 70518-2124; 63629-8723; 72572-761; 67877-280; 55500-0010; 50090-5581; 68992-3010; 51552-1403; 72572-760; 16714-099; 68462-687; 82160-124; 70518-3388; 43817-422; 52076-6222
Synonyms Tacrolimus | Prograf | Prograft | FR-900506 | FR 900506 | FR900506 | Anhydrous Tacrolimus | Tacrolimus, Anhydrous | Tacrolimus Anhydrous | Anhydrous, Tacrolimus | FK-506 | FK 506 | FK506
Chemical Information
Molecular Formula C44H69NO12
CAS Registry Number 104987-11-3
SMILES CC1CC(C2C(CC(C(O2)(C(=O)C(=O)N3CCCCC3C(=O)OC(C(C(CC(=O)C(C=C(C1)C)CC=C)O)C)C(=CC 4CCC(C(C4)OC)O)C)O)C)OC)OC
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Nephropathy toxicCalcineurin subunit B type 1P63098Not Available8591053; 7694398; 7592869; 7533090
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Segmented hyalinising vasculitis24.05.02.024; 10.02.02.027; 23.06.02.0090.003548%Not Available
Pneumonia cryptococcal22.07.08.012; 11.03.04.0050.003548%Not Available
Skin plaque23.03.03.0440.001419%Not Available
Hyperlipasaemia14.11.01.0230.001419%Not Available
Graft versus host disease in lung22.01.01.021; 12.02.09.030; 10.02.01.0610.000370%Not Available
Malacoplakia gastrointestinal11.07.01.017; 07.08.03.0160.002129%Not Available
Gastroenteritis norovirus11.05.22.001; 07.19.03.0170.006387%Not Available
Oral allergy syndrome10.01.01.0330.007097%Not Available
Capillaritis24.05.02.017; 23.06.02.0070.002129%Not Available
Anti-erythropoietin antibody negative13.01.03.0060.001419%Not Available
Burkholderia cepacia complex infection11.02.27.0010.000555%Not Available
Coma scale abnormal13.07.03.0120.002839%Not Available
Clostridium test positive13.08.01.0070.001419%Not Available
Superficial siderosis of central nervous system17.08.02.024; 14.13.03.007; 04.02.01.0160.001419%Not Available
Subchorionic haemorrhage24.07.03.030; 18.02.01.0070.001419%Not Available
Epstein-Barr virus associated lymphoma16.28.01.003; 11.05.10.007; 01.15.01.0030.000370%Not Available
Foetal monitoring abnormal13.21.01.0070.002129%Not Available
Neuroendocrine carcinoma metastatic16.24.01.008; 05.08.01.0120.001419%Not Available
Chronic graft versus host disease in intestine12.02.09.023; 10.02.01.055; 07.11.01.0220.000926%Not Available
Chronic graft versus host disease in skin23.07.04.022; 12.02.09.025; 10.02.01.0570.004258%Not Available
Chronic graft versus host disease in liver12.02.09.024; 09.01.07.032; 10.02.01.0560.000926%Not Available
Trichodysplasia spinulosa23.03.08.015; 10.03.02.0040.003548%Not Available
Prerenal failure24.06.02.025; 20.01.03.0220.001419%Not Available
Meniscus injury15.07.03.006; 12.04.03.0080.001419%Not Available
Preterm premature rupture of membranes18.02.02.0160.001419%Not Available
Abdominal lymphadenopathy07.11.01.018; 01.09.01.0200.000370%Not Available
Diabetic metabolic decompensation14.07.03.003; 05.07.03.0030.001419%Not Available
Nonreassuring foetal heart rate pattern18.03.02.017; 02.03.02.0270.001419%Not Available
Graft versus host disease in gastrointestinal tract12.02.09.028; 10.02.01.059; 07.11.01.0270.002962%Not Available
Purtscher retinopathy12.01.04.029; 06.10.02.006; 24.04.10.0070.005678%Not Available
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